Strategic vision

The task force aims to strengthen the scientific underpinnings for the TTC concept and expand its applicability as a risk assessment tool for substances to which humans are exposed at low levels.

Background

Based on the Threshold of Regulation (ToR) that was introduced by the US Food and Drug Administration, TTC concept is a science-based tool to help regulators and industry assess potential health risk from substances when specific toxicological data are not yet available.

Objectives

Where applicable, the use of the TTC principle enables us to:

prioritise toxicological testing based on estimated human exposures;

reduce the use of laboratory animals;

make better use of financial and human resources in both industry and public sector.

Achieved Results

The expert group created a database describing the TTC application for cosmetics-related substances and has published their findings in Regulator y Toxicology and Pharmacology (Williams et al. 2016).
The EUROTOX Continuing Education Course (CEC), organised in collaboration with the Packaging Materials (PM) and the Chemical Risk Assessment (CRA) task forces, provides an overview of current non-animal methods to deal with data gaps in hazard and exposure assessment (8 September 2019, Helsinki, FI

Objectives

The task force aims to strengthen the scientific underpinnings for the TTC and expand its applicability as an important risk assessment tool for substances to which humans are exposed at low levels. We strive to develop the most scientifically robust, yet pragmatic, non-animal, safety assessment tool.

Expert Groups

Background & Objectives
The probabilistic approach using the genotoxicity and non-cancer (Cramer class) Thresholds of Toxicological Concern (TTC) is often perceived as accepting a higher risk than traditional risk assessments. However, robust scientific activities to describe the sources of uncertainty within the TTC approach have not yet been conducted or published.

Output
The expert group examines how much uncertainty may be associated with the application of the TTC approach as compared to a substance-specific risk assessment. The group expects to produce two reviews:

an initial focus on qualitative description and ranking of the identified sources of uncertainty;

a subsequent quantitative assessment of the remaining quantifiable uncertainties.

Two ses sions at EUROTOX 2019 on 8 -11 September 2019 in Helsinki, FI, in collaboration with Alternatives to Animal Testing (AAT) and the Chemical-Risk Assessment (CRA) Task Forces.

Joint session with AAT and CRA Task Forces at the 21st International Congress for the European Society of Toxicology In Vitro (ESTIV), on 8-11 June 2020 in Barcelona, ES on application of non-animal methods and concepts in food risk assessment.